Oxycodone Sustained Release Matrix for 24-Hour Pain Relief
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Solution Overview
Problem
Current opioid formulations do not provide sustained pain relief for an extended period, as they have a short half-life and require frequent administration, which is inconvenient for patients.
Innovation Solution
A sustained release formulation of oxycodone or its pharmaceutically acceptable salt, combined with a sustained release material, is developed to maintain analgesic effects for at least 24 hours, with a controlled release profile that includes a matrix or osmotic dosage form to regulate oxycodone levels in the bloodstream.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Duration of action of moving object
If conventional opioid formulations are used, then the drug is administered frequently to maintain therapeutic effect, but the duration of action is short and patient convenience deteriorates
Solution Approach 1:
The formulation segments the release of oxycodone into multiple phases using a layered matrix structure with immediate-release and sustained-release components, enabling the drug to be released in controlled amounts over an extended period of 24 hours or more, thereby reducing administration frequency from multiple times daily to once daily
Solution Approach 2:
The formulation incorporates a preliminary burst release mechanism where an initial portion of oxycodone is released immediately upon administration to provide rapid pain relief, followed by sustained release from the matrix to maintain therapeutic levels, thereby achieving both immediate and prolonged effect in a single dose
2Speed
If the release rate is increased to provide faster pain relief, then the onset of action is improved, but the duration of sustained release is reduced
Solution Approach 1:
The formulation divides the oxycodone release into two distinct segments: an immediate-release portion that provides rapid onset of action for quick pain relief, and a sustained-release matrix portion that gradually releases the remaining drug over 24 hours or more, thereby achieving both fast onset and prolonged duration simultaneously
Solution Approach 2:
Different regions of the formulation have different release characteristics - the outer layer or surface provides faster release for immediate effect, while the inner matrix provides slower, sustained release, creating spatial variation in release rate that satisfies both rapid onset and extended duration requirements
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
The formulation provides effective pain management for 24 hours with a controlled release of oxycodone, maintaining therapeutic blood levels and reducing the frequency of administration, suitable for both acute and chronic pain conditions.
Implementation Method 1
a sustained release material, the dosage form providing an analgesic effect for at least about 24 hours after oral administration at steady state
Implementation Method 2
the in-vitro release rate, of oxycodone or a pharmaceutically acceptable salt thereof, when measured by the USP Basket Method at 100 rpm in 900 ml aqueous buffer at a pH of between 1.6 and 7.2 at 37° C.
Data Source
AI summary
The invention is directed to sustained release formulations containing oxycodone or a pharmaceutically acceptable salt thereof which provide a mean C24/Cmax oxycodone ratio of 0.6 to 1.0 or 0.7 to 1 after oral administration at steady state to patients and methods thereof.